510(k) · Cleared

Cleared

Alpha Micron 20 Microaggregate Filter

K955515510(k) TraditionalCleared Feb 12, 199670-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alpha Therapeutic Corp. · CAK Microfilter, Blood Transfusion

Cleared on Feb 12, 1996 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Feb 12, 1996
Review: 70 days
Class: Class II
Product code: CAK
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK955515 Alpha Micron 20 Microaggregate FilterAlpha Therapeutic Corp. · 1996
Descendant · cites it directly · 0 of its ownK970225 Alpha Micron 20/40 Microaggregate FilterAlpha Therapeutic Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all

K970225Alpha Micron 20/40 Microaggregate FilterAlpha Therapeutic Corp. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955515	Alpha Micron 20 Microaggregate Filter	Alpha Therapeutic Corp.	1996	—
+1	K970225	Alpha Micron 20/40 Microaggregate Filter	Alpha Therapeutic Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K955515, 1996–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K970225	Alpha Micron 20/40 Microaggregate Filter	Alpha Therapeutic Corp.	1997	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K970225 (Alpha Therapeutic Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CAK devices

CAK Microfilter, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAK

FDA has decided no CAK device since 2007.

Median 510(k) review, days · CAK

Too few CAK 510(k)s in any year since 2007 to give a median.

Recalls per year · CAK

No recall names CAK since 2007.

Adverse event reports per year · CAK

60in 2025

2007high 334 (2019) · low 0 (2012)2025

MAUDE reports naming product code CAK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	5
2008	—	7
2009	—	8
2010	—	3
2011	—	4
2012	—	0
2013	—	104
2014	—	37
2015	—	58
2016	—	97
2017	—	131
2018	—	58
2019	—	334
2020	—	180
2021	—	18
2022	—	110
2023	—	69
2024	—	19
2025	—	60
2026	—	—

https://510kreport.com/device/K955515 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955515: Alpha Micron 20 Microaggregate Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955515

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026